EP4234569A3 - Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique - Google Patents

Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique Download PDF

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Publication number
EP4234569A3
EP4234569A3 EP23172012.9A EP23172012A EP4234569A3 EP 4234569 A3 EP4234569 A3 EP 4234569A3 EP 23172012 A EP23172012 A EP 23172012A EP 4234569 A3 EP4234569 A3 EP 4234569A3
Authority
EP
European Patent Office
Prior art keywords
treatment
biological product
composition
treatment composition
during manufacture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23172012.9A
Other languages
German (de)
English (en)
Other versions
EP4234569A2 (fr
Inventor
Jonathan COFFMAN
Jeff GOBY
Scott Godfrey
Raquel OROZCO
Jens Holger Vogel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Publication of EP4234569A2 publication Critical patent/EP4234569A2/fr
Publication of EP4234569A3 publication Critical patent/EP4234569A3/fr
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/00061—Methods of inactivation or attenuation
    • C12N2710/00063—Methods of inactivation or attenuation by chemical treatment

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Virology (AREA)
  • Biotechnology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
EP23172012.9A 2014-04-15 2015-04-15 Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique Pending EP4234569A3 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461979731P 2014-04-15 2014-04-15
PCT/EP2015/058172 WO2015158776A1 (fr) 2014-04-15 2015-04-15 Procédés, appareils et systèmes d'inactivation continue de virus pendant la fabrication de produit biologique
EP15720615.2A EP3131589B1 (fr) 2014-04-15 2015-04-15 Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP15720615.2A Division EP3131589B1 (fr) 2014-04-15 2015-04-15 Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique

Publications (2)

Publication Number Publication Date
EP4234569A2 EP4234569A2 (fr) 2023-08-30
EP4234569A3 true EP4234569A3 (fr) 2023-10-18

Family

ID=53052800

Family Applications (2)

Application Number Title Priority Date Filing Date
EP15720615.2A Active EP3131589B1 (fr) 2014-04-15 2015-04-15 Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique
EP23172012.9A Pending EP4234569A3 (fr) 2014-04-15 2015-04-15 Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP15720615.2A Active EP3131589B1 (fr) 2014-04-15 2015-04-15 Procédé et utilisation d'inactivation continue de virus pendant la fabrication de produit biologique

Country Status (5)

Country Link
US (3) US10435670B2 (fr)
EP (2) EP3131589B1 (fr)
CN (3) CN106456813B (fr)
DK (1) DK3131589T3 (fr)
WO (1) WO2015158776A1 (fr)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106456813B (zh) 2014-04-15 2020-06-30 勃林格殷格翰国际公司 在制造生物制品期间连续灭活病毒的方法、装置和***
DE102016202139A1 (de) * 2016-02-12 2017-08-17 Hamilton Bonaduz Ag Zellvereinzelungsvorrichtung und Verwendung einer Strömungsformation zur Zellvereinzelungsvorrichtung
KR102550844B1 (ko) * 2016-03-11 2023-07-05 베링거 인겔하임 인터내셔날 게엠베하 단백질의 제조 동안 바이러스를 연속적으로 불활성화시키는 방법
WO2017174580A1 (fr) * 2016-04-04 2017-10-12 Boehringer Ingelheim Rcv Gmbh & Co Kg Surveillance en temps réel de purification de produit
CN110831682A (zh) 2017-05-11 2020-02-21 Emd密理博公司 在连续流动体系中保持窄停留时间分布的方法
JP7117329B2 (ja) * 2017-05-11 2022-08-12 イー・エム・デイー・ミリポア・コーポレイシヨン 連続流動システムにおける狭い滞留時間分布を維持する機械的方法
AU2018299920B2 (en) 2017-07-10 2024-04-11 Takeda Pharmaceutical Company Limited Method for incubating liquids and inactivating viruses
EP3723500A1 (fr) * 2017-12-13 2020-10-21 Bayer Aktiengesellschaft Unité fonctionnelle et son utilisation
US20210380914A1 (en) * 2018-10-08 2021-12-09 Boehringer Ingelheim International Gmbh Novel continuous flow reactor for low ph viral inactivation
CA3119629A1 (fr) * 2018-11-15 2020-05-22 Bayer Healthcare Llc Procedes d'inactivation virale pour la fabrication continue d'anticorps
KR20210023102A (ko) 2019-08-22 2021-03-04 (주)아모레퍼시픽 눈썹 또는 속눈썹 성장 촉진용 조성물
EP4164780A1 (fr) 2020-06-16 2023-04-19 Boehringer Ingelheim International GmbH Procédé de fourniture d'un flux d'alimentation homogène à l'intérieur d'un réacteur en écoulement piston
CN111690057B (zh) * 2020-06-24 2021-04-23 哈尔滨元亨生物药业有限公司 一种重组犬细小病毒单克隆抗体生产方法
DE102021107394A1 (de) 2021-03-24 2022-09-29 Sartorius Stedim Biotech Gmbh Vorrichtung zur kontinuierlichen Vireninaktivierung

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000020045A1 (fr) * 1998-10-02 2000-04-13 Common Services Agency Dispositif pour traitement de liquides biologiques
EP1775000A2 (fr) * 1999-02-22 2007-04-18 NCSRT, Inc. Méthode pour produir de plasma sanguin du sang
WO2014004103A1 (fr) * 2012-06-29 2014-01-03 Emd Millipore Corporation Méthodes permettant d'inactiver des virus lors d'un procédé de purification de protéines
EP2682168A1 (fr) * 2012-07-02 2014-01-08 Millipore Corporation Dispositif de tirage et métier à filer

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AU698154B2 (en) 1993-06-23 1998-10-22 New York Blood Center, Inc., The System for viral inactivation of blood
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CN106456813B (zh) 2014-04-15 2020-06-30 勃林格殷格翰国际公司 在制造生物制品期间连续灭活病毒的方法、装置和***

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000020045A1 (fr) * 1998-10-02 2000-04-13 Common Services Agency Dispositif pour traitement de liquides biologiques
EP1775000A2 (fr) * 1999-02-22 2007-04-18 NCSRT, Inc. Méthode pour produir de plasma sanguin du sang
WO2014004103A1 (fr) * 2012-06-29 2014-01-03 Emd Millipore Corporation Méthodes permettant d'inactiver des virus lors d'un procédé de purification de protéines
EP2682168A1 (fr) * 2012-07-02 2014-01-08 Millipore Corporation Dispositif de tirage et métier à filer

Also Published As

Publication number Publication date
CN106456813A (zh) 2017-02-22
WO2015158776A1 (fr) 2015-10-22
CN111632167B (zh) 2021-12-28
CN114225072B (zh) 2024-01-02
CN106456813B (zh) 2020-06-30
US20230340425A1 (en) 2023-10-26
CN111632167A (zh) 2020-09-08
US20170037381A1 (en) 2017-02-09
EP4234569A2 (fr) 2023-08-30
DK3131589T3 (da) 2023-08-07
EP3131589A1 (fr) 2017-02-22
US11725191B2 (en) 2023-08-15
EP3131589B1 (fr) 2023-05-17
CN114225072A (zh) 2022-03-25
US10435670B2 (en) 2019-10-08
US20200087632A1 (en) 2020-03-19

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